A MESSAGE FROM THE FOUNDER - WHO I AM

I think it's important for participants to know that I am not a researcher, sponsor, clinic employee, or regulator. I am a healthy volunteer just like you!

I first started participating in studies at Celerion in Lincoln, near my hometown, back in the 1990s and continued on and off over the years.

After retiring about 11 years ago, I returned to doing studies full time. When I turned 55, I realized something I had not paid much attention to before. Even though I was still healthy, I found myself being excluded from studies because of some clinics' arbitrary age cutoff requirements.

The more I looked into this issue, I was unable to find any scientific justification for many of these exclusions. In fact, the FDA has encouraged the inclusion of healthy older adults in clinical research whenever appropriate. Unfortunately, because there are currently no clear guidelines governing the use of age cutoffs, clinics are still allowed to impose arbitrary age restrictions if they choose.

That experience made me start paying closer attention to some of the other challenges we face, and I started asking questions about whether those decisions were always fair or justified.

I’ll be honest, like many healthy volunteers, I originally started participating in studies because I needed the money. Over time, however, I started paying closer attention to the experiences of other participants and the many unfair situations we face while participating in studies. I understand why some people may be hesitant to trust another organization, even one such as HVA, that was designed specifically to advocate for them. Many participants have spent years feeling like they have nobody trustworthy to turn to when situations arise and no one to turn to for answers.

In the last year, I became involved in online participant chat groups where volunteers share their experiences. The more conversations and the more stories I heard, the more I realized that many of the concerns being discussed were not just one-time incidents. The same issues kept coming up over and over again from participant experiences across all different clinics.

I think we all know what the main concerns are:

• Being banned or restricted from studies without clear explanations and no way to appeal. 

• No meaningful way to challenge decisions or even understand why they were made.

• Inaccurate information placed in our records that affect future study opportunities and no clear pathway to resolve these issues.

• Fear of reporting a concern or even asking a question, because of being labeled a troublemaker or possibly of being banned for speaking up.

• What concerned me most was the lack of transparency and the feeling that participants often have no meaningful recourse because many do not know who to contact when problems arise or whether they should speak with study staff, clinic management, an IRB, a sponsor, or a regulatory agency.

In my opinion, the fear of speaking up is one of the biggest reasons participants have lost trust in the system. When people do not feel safe asking questions, reporting concerns, or speaking honestly about their experiences, many simply choose to stay quiet. Over time, that silence creates uncertainty and distrust because participants begin to feel that raising concerns carries more risk than benefit. So, keeping your mouth shut, head down, and collecting the money often becomes the safest avenue.

IRBs, ICF’s, sponsors, clinics, and regulatory oversight all play important roles in clinical research. The problem is not that these systems don’t exist. The problem is that many of us do not understand how these systems work, who is responsible for what, or where to turn when they need help. Even when volunteers do try to ask questions or raise concerns, they are often referred from one organization to another or told that a particular issue falls outside someone's role or responsibility, and/or sometimes even banned because of speaking out or raising concerns. 

After spending countless hours trying to find even one organization dedicated to representing healthy participants, I realized that we have no independent organization focused specifically on our concerns, yet so many organizations exist to protect the rights of patient participants. To me, this is unacceptable. We should not be made to feel that our issues, safety, health, or concerns do not matter.  Whether it is intentional or not, this is the unwritten message we receive from the current system.

I understand many of the issues we face because I have experienced some of them myself and have heard countless others from participants over the years. For example, I am currently banned at all three Fortrea clinics because of inaccurate information that was placed in my medical records by a screening P.I. I submitted documentation from my physician in an effort to clear up that record and get my ban lifted. Three months later, despite multiple emails, I still have not received a response. I'm sure many of you can relate to that one.

The goal of HVA was never to attack clinics, sponsors, researchers, or regulators. The goal was to create a voice for participants, encourage transparency and help ensure that healthy volunteers are treated fairly, with the respect, dignity, and protections we deserve.

I do not pretend to have all the answers, and I know change does not happen overnight. Since the idea for HVA came to me back in October, I have been criticized, doubted, and told that I was going about this the wrong way. Many people had strong opinions about what I should do or whether any of this would accomplish anything at all. As an open-minded person, I respect everyone's opinions and feedback, but ultimately I had to follow the approach that I felt was right. I need to be true to my vision, but that does not mean I stop valuing feedback or different perspectives. After all, HVA is for and about all of us!

Thank you all for taking your time to read my story. I hope you will consider sharing it with other participants so they can better understand the person behind HVA and know they can trust me and HVA to respect their privacy, protect their anonymity when requested, and always remember that I'm one of you.